Suspended

TILA Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer

What is being tested

Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection

Biological

Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

From 18 to 70 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: July 2022

See protocol details

Summary

Principal SponsorFudan University

Study ContactXiaohua Wu, MD, Ph.DMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2022

Actual date on which the first participant was enrolled.

For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.

Official TitleA Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer

NCT05475847

Principal SponsorFudan University

Study ContactXiaohua Wu, MD, Ph.DMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesUterine Cervical NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital Diseases

Criteria

8 inclusion criteria required to participate

Aged 18 to 70 years at screening

Voluntary participation and able to sign the informed consent form

Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment.

Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes

Show More Criteria

8 exclusion criteria prevent from participating

Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)

Symptomic chronic obstructive pulmonary disease or persistent asthma

Uncontrolled cardiovascular diseases

History of primary immune deficiency, autoimmune disease or chronic inflammatory disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District

Shanghai, ChinaOpen Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District in Google Maps

Recruiting

Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area

Shanghai, China

Suspended2 Study Centers